FDA Tells Vaccine Makers to Update Boosters to Target Omicron Subvariants

THURSDAY, June 30, 2022 (HealthDay News) -- The U.S. Food and Drug Administration announced Thursday that it has asked vaccine makers to update their COVID-19 booster shots to target the omicron subvariants known as BA.4 and BA.5. The two highly contagious subvariants now account for more than half of all new COVID-19 cases in the United States.

"As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19," Peter Marks, M.D., director of the FDA Center for Biologics Evaluation and Research, said in an agency news release. "Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an omicron BA.1 component and we have advised them that they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an omicron BA.4/5 component. Manufacturers will also be asked to begin clinical trials with modified vaccines containing an omicron BA.4/5 component, as these data will be of use as the pandemic further evolves."

The agency's decision mirrors the recommendation made Tuesday by its vaccine advisory panel that updated COVID-19 booster shots used this fall should protect against omicron and its highly contagious subvariants.

Pfizer and Moderna are expected to start producing reformulated doses this summer, The New York Times reported. During the expert panel meeting, Pfizer said a shot aimed at the subvariants could be ready for use in early October, while Moderna said it would be able to offer a similar shot in late October or early November. The vaccines produced by Pfizer and Moderna typically take about three months to produce doses of any reformulated shots.

The New York Times Article